{"product_id":"fda-510k-k203634","title":"FDA 510(k) K203634, BioPoly Great Toe Hemiarthroplasty Implant, by BioPoly, LLC","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eProsthesis, Toe, Hemi-, Phalangeal\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK203634\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e BioPoly Great Toe Hemiarthroplasty Implant\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e BioPoly, LLC\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e888.3730\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eKWD\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e12\/11\/2020\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 02\/02\/2021\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eOrthopedic\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eOrthopedic\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 2,040\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,672\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 368\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313221238948,"sku":"FDA510K203634","price":1025.22,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k203634","provider":"FOIA Document Source","version":"1.0","type":"link"}